基于六西格玛模式评价糖化血红蛋白的分析性能及质控策略的设计

Design of analysis performance and quality control strategy for evaluating HbA_(1c) based on six sigma model

目的应用六西格玛(6σ)模式评价糖化血红蛋白(HbA_(1c))的分析性能,并初步建立HbA_(1c)项目的室内质控策略和质量改进措施。方法收集本实验室HbA_(1c)项目2020年国家卫健委临床检验中心室间质评数据及2020年1月至6月两个浓度水平的室内质控数据,并结合四个不同来源的允许总误差(TEa)分别计算HbA_(1c)项目的σ水平,同时应用标准化的西格玛性能验证图进行标示。依据具有批长度的Westgard西格玛规则流程图和质量目标指数(QGI),制定HbA_(1c)项目的室内质控策略和质量改进方案。结果基于西班牙室间质评标准和德国RiliBAK标准作为质量目标时,HbA_(1c)的分析性能均处于“世界一流”水平;而基于“适当”生物学变异和我国室间质评标准作为质量目标时,HbA_(1c)的分析性能分别处于“不可接受”和“优秀”水平。本研究依据我国室间质评标准作为质量目标,同时结合具有批长度的Westgard西格玛规则,初步建立以下质控策略:选择13s/22s/R4s多规则(N=2)且分析批长度为450个患者的样本作为HbA_(1c)的室内质控方案。且QGI计算结果显示,HbA_(1c)项目的偏倚是影响其分析性能的主要因素,需优先在正确度的提升方面制定相应的改进措施。结论6σ模式能够客观评价HbA_(1c)项目的分析性能,且在实验室质控策略的设计和检测质量的改进方面具有重要的指导意义。

Objective The six sigma model was used to evaluate the analytical performance of glycosylated hemoglobin(HbA_(1c)),and the internal quality control(IQC)strategy and quality improvement measures for the HbA_(1c) was initially established.Methods The data of external quality assessment(EQA)of HbA_(1c) from National Center for Clinical Laboratories(NCCL)in 2020 and its IQC data of the two concentration levels from January to June 2020 were collected.And based on the allowable total error(TEa)from four different sources to calculate the sigma level of HbA_(1c) respectively.Meanwhile,analytical performance of HbA_(1c) was demonstrated on the standardized sigma performance verification chart.According to the Westgard sigma rule flow chart with batch length and quality goal index(QGI),IQC strategy and quality improvement plan of the HbA_(1c) were formulated.Results The analytical performance of HbA_(1c) was at the"world-class"level based on the Spanish EQA standard and the German RiliBAK standard,while the quality goals were based on the"desirable"biological variation and EQA standard of China,analytical performance of HbA_(1c) was at the"unacceptable"and"excellent"levels,respectively.This study was based on EQA standard of China as the quality goal,and combined with the Westgard sigma rule with batch length,and initially established the following IQC strategy:13s/22s/R4s multiple rules(N=2)with batch length of 450 samples was selected as the IQC strategy for HbA_(1c).Besides,the calculation of QGI showed that the bias of HbA_(1c) was the main factor affecting its analytical performance,and it was necessary to prioritize the formulation of corresponding improvement measures in terms of accuracy.Conclusion The six sigma model can objectively evaluate the analytical performance of HbA_(1c),and has important guiding significance in the design of laboratory quality control strategies and the improvement of detection quality.